Oligometastasis wth two to five extracranial and not more than three ZNS lesions
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ICD-10: C00-25, C30-34(NSCLC only), C37, C39, C44-45, C48, C50 (hormone-resistant only), C51-58, C60-61 (castration-resistant only), C63-69, C73-74, and C80 oligometastatic disease with =5 extracranial lesions and =3 intrecebral lesions wihtout presious treatment, after relapse after complete remission or partial remission patient qualifies for cytotoxic systemic therapy normal blood counts (Hb>8g/dl, ANC>1500/mm³, thrombocytes >100 000/mm³) normal liver function tests (ASAT/ALAT/AP=2.5*ULN), if liver metastatic and to be treated: 50 ml/min ability to understand research protocol and willing to comply with reassessments and follow-ups consent to have the patient’s case re-discussed in interdisciplinary tumor boards. negative pregnancy test for female patients aged <50 yrs. if sexually active, ability to use pregnancy prevention methods until 12 months after ending chemotherapy. male patients restrain from fostering a child until 12 months after last chemotherapy
Exclusion criteria
Exclusion criteria: Extragonadal germ cell tumor Tumor or carcinoma with neuroendocrine features Peritoneal carcinomatosis Hormone-sensitive breast cancer Hormone-sensitive prostate cancer Sarcoma Melanoma Chorioncarcinoma Hematooncological neoplasia Chemotherapy within the last three months Age = 18 yrs. previous radiotherapy to at least one of the areas currently presenting with oligometastatic disease, exceptions are brain metastasis, and metastasis with compression of the spinal cord pregnancy or lactation patients not compliant with birth control measurements previous or ongoing abuse of medical substances, drugs, or alcohol non-compliance in respect of protocol requirements and follow-ups uncontrolled physical or mental disabilities - including instable angina - cardiac ischemia within the last 3 months - active/treated neurological/psychiatric diagnosis incl. dementia/seizures - active, not controlled infectious disease or bacteremia patients with a history of previous malignant disease, except successfully treated basal cell cancer of the skin or carcinoma-in-situ of the uterine cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival time to retreatment | — |
Countries
Germany, Switzerland
Contacts
Städtisches Klinikum Dessau